Loading clinical trials...

A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) | Clinical Trials | Clareo Health

RECRUITING

A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)

STRIDE II: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System II

NCT06747117•Penumbra Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years
•Patients with a confirmed diagnosis of lower limb arterial occlusion located in the common iliac or below, with a minimum of 2 cm of proximal patency in the common iliac
•Acute occlusion with symptom duration of 14 days or less at presentation
•ALI Rutherford Category I, IIa or IIb
•First-line treatment with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy (CAVT) aspiration tubing
•Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements
•Previously enrolled patients presenting with a new acute occlusion in the contralateral limb meeting all eligibility criteria may be re-enrolled if the new acute occlusion is greater than 30 days from the initial index procedure

Exclusion Criteria

•Life expectancy \<1 year
•Target vessel size \<2 mm
•Target thrombus is in the aorta or isolated profunda artery
•Prior major amputation (proximal to the tarsometatarsal joint) in the target limb
•Prior minor amputation in the target limb within the past 6 months that is not completely healed or cannot bear weight
•LE ALI secondary to dissection, vasculitis, or target vessel trauma, including iatrogenic etiology from treatment of a proximal location in the target limb, and non-thrombotic material such as tumor fragments, fat emboli, septic emboli, and foreign bodies
•Target thrombus in a vein bypass graft, previously revised bypass grafts, bypass grafts placed \< 3 months prior to index ALI symptom onset, or bypass grafts with a distal anastomosis below the popliteal artery
•Treatment of the index event with thrombolytics or any other endovascular or open surgical method prior to enrollment
•Pregnancy
•Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
+2 more criteria

Locations (26)

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, United States

Community Memorial Hospital

Ventura, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Christiana Care Health Services, Inc.

Newark, Delaware, United States

University of Florida Shands Hospital

Gainesville, Florida, United States

Radiology and Imaging Specialists

Lakeland, Florida, United States

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Miami, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Community Hospital

Munster, Indiana, United States

Key Dates

Start Date

May 18, 2025

Primary Completion Date

June 1, 2028

Completion Date

January 1, 2029

Last Updated

March 13, 2026

Enrollment

300

ESTIMATED participants

Conditions

Lower Extremity Acute Limb IschemiaLE ALI

Interventions

Indigo Aspiration System

DEVICE

Contacts

Marina Mello

CONTACT

+14078108634 mmello@penumbrainc.com

Jemymah Allen

CONTACT

+13109485738 jallen@penumbrainc.com